NCT05012215

Brief Summary

To compare the efficacy of Ultrasound guided thoracic paravertebral block versus ultrasound guided caudal epidural block in pediatric patients undergoing percutaneous nephrolithotomy

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 19, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

August 19, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2022

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

7 months

First QC Date

August 6, 2021

Last Update Submit

August 19, 2021

Conditions

Kidney StonesPercutaneous Nephrolithotomy

Keywords

paravertebral blockcaudal blockPercutaneous nephrolithotomypediatric

Outcome Measures

Primary Outcomes (4)

  • Blood pressure during surgery in mmHg

    through the surgery, an average of 2 hours

  • Heart rate (beats/minute)

    through the surgery, an average of 2 hours

  • The concentration of sevoflurane in %

    through the surgery, an average of 2 hours

  • Postoperative pain using FLACC score

    up to 12 hours

Study Arms (2)

Paravertebral

EXPERIMENTAL

Ultrasound-guided thoracic paravertebral block

Procedure: Paravertebral

Caudal

ACTIVE COMPARATOR

Caudal block

Procedure: Caudal block

Interventions

ParavertebralPROCEDURE

Ultrasound-guided paravertebral block

Paravertebral
Caudal blockPROCEDURE

Caudal block

Caudal

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients undergoing percutaneous nephrolithotomy

You may not qualify if:

  • Coagulation disorders
  • Infection at the site of injection
  • Allergy to the local anesthetics used
  • Spinal cord abnormalities or neurological deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Hany M. Osman, M.D.

CONTACT

+201002414591hanymeo@aun.edu.eg

Fatma N. Mohamed, M.D.

CONTACT

fatmanabil2012@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 6, 2021

First Posted

August 19, 2021

Study Start

August 19, 2021

Primary Completion

March 20, 2022

Study Completion

March 20, 2022

Last Updated

August 20, 2021

Record last verified: 2021-08

Locations

EG(1)